"The U.S. Food and Drug Administration today approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting.
Diclegis is a delayed-release tablet intended for women who have"...
Diclegis Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Diclegis (doxylamine succinate and pyridoxine hydrochloride) is used to treat nausea and vomiting in pregnant women. Diclegis is not available in generic form. Diclegis belongs to a class of medications called antiemetic (anti-nausea and vomiting) agents. Diclegis should be used with caution, especially with respect to activities that require complete mental alertness. Diclegis depresses the central nervous system and should not be used with alcohol.
Diclegis are available as delayed-release tablets containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. Patients should take two tablets of Diclegis at bedtime. If nausea and vomiting is not controlled with two tablets, the dose may be increased to a maximum of four tablets daily. Diclegis should not be used by women with sensitivities to any ingredient in Diclegis. Severe drowsiness can occur when using Diclegis with other sedative medications.
Diclegis is intended for use in pregnant women. Women should not breastfeed while using Diclegis.
Our Diclegis (doxylamine succinate and pyridoxine hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Diclegis FDA Prescribing Information: Side Effects
The following adverse reactions are discussed elsewhere in the labeling:
- Somnolence [see WARNINGS AND PRECAUTIONS]
- Falls or other accidents resulting from the effect of the combined use of DICLEGIS with CNS depressants including alcohol [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety and efficacy of DICLEGIS were compared to placebo in a double-blind, randomized, multi-center trial in 261 women with nausea and vomiting of pregnancy. The mean gestational age at enrollment was 9.3 weeks, range 7 to 14 weeks gestation [see Clinical Studies]. Adverse reactions for DICLEGIS that occurred at an incidence ≥ 5 percent and exceeded the incidence for placebo are summarized in Table 1.
Table 1: Number (Percent) of Subjects with ≥ 5
Percent Adverse Reactions in a 15-Day Placebo- Controlled Study of DICLEGIS
(Only Those Adverse Reactions Occurring at an Incidence ≥ 5 Percent and
at a Higher Incidence with DIGLEGIS than Placebo are Shown)
(N = 133)
(n = 128)
|Somnolence||19 (14.3%)||15 (11.7%)|
The following adverse events, listed alphabetically, have been identified during post-approval use of the combination of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Ear and labyrinth disorders: vertigo
Eye disorders: vision blurred, visual disturbances
Gastrointestinal disorders: abdominal distension, abdominal pain, constipation, diarrhea
General disorders and administration site conditions: chest discomfort, fatigue, irritability, malaise
Immune system disorders: hypersensitivity
Psychiatric disorders: anxiety, disorientation, insomnia, nightmares
Renal and urinary disorders: dysuria, urinary retention
Read the entire FDA prescribing information for Diclegis (Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release Tablets) »
Additional Diclegis Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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